A Performance Evaluation of the Enlite Glucose Sensor to Support a Full 144 Hours(6Days) of Use

NCT01464346 | Completed Results DMC FDA Device

• 1 other identifier: CEP247
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 7

Brief Summary

The purpose of this study is to demonstrate the performance of the Enlite Sensor over an entire calibration and wear period of 146 hours (6 days) when inserted in the abdomen and buttock and used with the Revel 2.0 Pumps in subjects age 18 - 75 years.

Conditions

Type 1 Diabetes Mellitus; Type 2 Diabetes Mellitus

Keywords

diabetes; glucose sensor; CGM

Outcome Measures

Primary Outcomes (1)

• Mean Daily Agreement (Percent of Sensor Values Within 30% of Reference Value) With Minimum Calibration, Combined Abdomen and Buttock Insertion Sites

  Primary endpoint is mean of daily percentage of sensor values within 30% of reference value (within 22.5 mg/dL if YSI \<75 mg/dL) with the minimum calibration (every 12 hour), combined abdomen and buttock insertion sites across all participants and all days.

  Days 1, 3 and 6 of sensor wear

Secondary Outcomes (1)

• Mean Daily Agreement (Percent of Sensor Values Within 30% of Reference Value) With 3-4 Calibrations Per Day, Combined Abdomen and Buttock Insertion

  Days 1, 3 and 6 of sensor wear

Other Outcomes (4)

• Mean Absolute Relative Difference (MARD) Between Sensor and YSI for Abdomen Insertion Site, With 3-4 Calibrations Throughout the Day

  Days 1, 3 and 6 of sensor wear

• Mean Absolute Relative Difference (MARD) Between Sensor and YSI for Abdomen Insertion Site, With Calibration Every 12 Hours

  Days 1, 3 and 6 of sensor wear

• Mean Absolute Relative Difference (MARD) Between Sensor and YSI for Buttock Insertion Site, With 3-4 Calibrations Throughout the Day

  Days 1, 3 and 6 of sensor wear

Study Arms (3)

Enlite sensor, Abdomen/Abdomen

EXPERIMENTAL

Subjects wearing 2 Enlite sensors in Abdomen

Device: Enlite Sensor

Enlite sensor, Abdomen/Buttock

EXPERIMENTAL

Subjects wearing 2 Enlite sensors in Abdomen/Buttock

Device: Enlite Sensor

Enlite sensor, Buttock/Buttock

EXPERIMENTAL

Subjects wearing 2 Enlite sensors in Buttock/Buttock

Device: Enlite Sensor

Interventions

Enlite Sensor DEVICE

This is the Enlite sensor (all subjects)

Enlite sensor, Abdomen/Abdomen; Enlite sensor, Abdomen/Buttock; Enlite sensor, Buttock/Buttock

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is 18 - 75 years of age at time of screening
• A clinical diagnosis of type 1 or 2 diabetes as determined by the
• Investigator, for a minimum of 12 months duration:
• Criteria for type 1 diabetes:
• Required: Age of onset \< 40 years of age
• Required: History of insulin use only for management of diabetes
• Required: history of normal weight or underweight at time of diagnosis.
• Not required: Initial presentation of diabetic ketoacidosis.
• Not required: History of diabetic ketoacidosis
• Not required: Low fasting C-peptide
• Criteria for type 2 diabetes:
• Required: Age of onset \~ 40 years of age
• Required: History of initial oral anti-diabetic use
• Required: History of being overweight at time of diagnosis.
• Type 2 insulin requiring is defined by type 2 diabetes subjects taking insulin with or without oral anti-diabetic agent and may also include: incretin mimetic, pramlintide or GLP agonist

You may not qualify if:

• Subject is unable to tolerate tape adhesive in the area of sensor placement.
• Subject has any unresolved adverse skin condition in the area of sensor or device placement (e.g., psoriasis, rash, Staphylococcus infection)
• Subject is actively participating in an investigational study (drug or device) wherein they have received treatment from an investigational study (drug or device) in the last 2 weeks
• Subject has a positive pregnancy screening test
• Subject is female and plans to become pregnant during the course of the study
• Subject has had a hypoglycemic seizure within the past 6 months
• Subject has a history of a seizure disorder
• Subject has central nervous system or cardiac disorder resulting in syncope
• Subject has a history of myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack (TIA), cerebrovascular accident (CVA), angina, congestive heart failure, ventricular rhythm disturbances or thromboembolic disease
• Subjects with hematocrit lower than 36%
• SUbjects with a history of any cardiac arrhythmia, including atrial arrhythmias
• Subjects with a history of adrenal insufficiency
• Subjects with migraines

Sponsors & Collaborators

• Medtronic Diabetes: lead

Study Sites (7)

Profil Institute for Clinical Research

Chula Vista, California, 91911, United States

Location

AMCR Institue

Escondido, California, 92026, United States

Location

University of California, San Diego

La Jolla, California, 92093, United States

Location

Diablo Clinical Research

Walnut Creek, California, 94598, United States

Location

University of Colorado Denver/Barbara Davis Center for Childhood Diabetes

Aurora, Colorado, 80045, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Rainier Clinical Research Center

Renton, Washington, 98057, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Pamela Haworth
• Organization: Medtronic Diabetes Clinical Research

pamela.c.haworth@medtronic.com

Study Officials

• Scott Lee, MD

  Medtronic Diabetes

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2011
• First Posted: November 3, 2011
• Study Start: November 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: May 30, 2018
• Results First Posted: May 30, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)